Aminosyn Sulfite Free

Aminosyn Sulfite Free

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Questions & Answers

Side Effects & Adverse Reactions

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.

Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.

Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants.

Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined, but may involve genetic defects and immature or subclinically impaired liver function.

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) can be infused simultaneously with fat emulsion by means of a Y-connector located near the infusion site using separate flow rate controls for each solution.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate.

SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT ELECTROLYTES.

Aminosyn 10% (pH 6) can be administered peripherally with dilute (5% to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support in patients who, while not hypermetabolic, cannot be satisfactorily maintained on peripheral intravenous nutrition. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate.

When administered with concentrated dextrose solutions with or without fat emulsions, Aminosyn 10% (pH 6) is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where: (a) the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein are substantially increased as with extensive burns and (d) morbidity and mortality may be reduced by replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute renal failure.

History

There is currently no drug history available for this drug.

Other Information

Aminosyn® 10% (pH 6), Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn 10% (pH 6) is oxygen sensitive.

Essential Amino Acids (mg/100 mL)

Aminosyn (pH 6)

10%

Isoleucine

720

Leucine

940

Lysine (acetate)*

720

Methionine

400

Phenylalanine

440

Threonine

520

Tryptophan

160

Valine

800

*Amount cited is for L-lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Aminosyn (pH 6)

10%

Alanine

1280

Arginine

980

Histidine

300

Proline

860

Serine

420

Tyrosine

44

Glycine

1280

Electrolytes (mEq/Liter)

Aminosyn (pH 6)

10%

Potassium (K+)

None

Chloride (Cl-)

None

Acetate (C2H3O2-)b

111a

a Includes acetate from acetic acid used in processing and from L-lysine acetate.

b Adjusted with acetic acid.

Product Characteristics

Aminosyn (pH 6)

10%

Protein Equivalent

    (approx. grams/liter)

100

Total Nitrogen

    (grams/liter)

15.7

Osmolarity

    (mOsmol/liter)

938

pH

6.0 (5.5 − 6.5)b

b Adjusted with acetic acid.

The formulas for the individual amino acids present in Aminosyn 10% (pH 6) are as follows:

Essential Amino Acids

Isoleucine, USP

C6H13NO2

Leucine, USP

C6H13NO2

Lysine Acetate, USP

C6H14N2O2 • CH3COOH

Methionine, USP

C5H11NO2S

Phenylalanine, USP

C9H11NO2

Threonine, USP

C4H9NO3

Tryptophan, USP

C11H12N2O2

Valine, USP

C5H11NO2

Nonessential Amino Acids

Alanine, USP

C3H7NO2

Arginine, USP

C6H14N4O2

Histidine, USP

C6H9N3O2

Proline, USP

C5H9NO2

Serine, USP

C3H7NO3

Tyrosine, USP

C9H11NO3

Glycine, USP

C2H5NO2

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Aminosyn Sulfite Free Manufacturers


  • Hospira, Inc.
    Aminosyn Sulfite Free (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine) Injection, Solution [Hospira, Inc.]

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